A Safety Study of Orally Administered BPM31510 in Healthy Subjects

April 4, 2017 updated by: Berg, LLC

A Phase I Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Orally Administered BPM31510 in Healthy Subjects

This is an open-label, Phase I study of the bioavailability and safety of BPM31510 administered orally in healthy subjects dosed 3 times daily for 14 days. The last study dose is administered on Day 15 (one morning dose only). The study will consist of 25 subjects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Study subjects will be admitted to the clinic on Day -1. All subjects will self-administer the Day 1 doses of study drug under supervision of the clinic staff. Doses of 3200 mg will be administered three times per day before meals.

Dosing will continue for an additional 14 days on an outpatient basis with Day 5 morning dose and the last study dose on Day 15 to be administered at the clinic (one morning dose, is given on Day 15).

On Days 1, 2, 5 and 15, pharmacokinetic (PK) and pharmacodynamics (PD) sampling will be performed 30 minutes prior to the first dose, and 0.5, 1, 2, and 4 hours after the first dose at all visits with an additional PK draw on Day 1 at 0.5, 1, 2, and 4 after the second dose. Urine for PK/PD will be collected pre-dose on Day 1, Day 2, Day 5 and Day 15. At all visits (on Days 1, 2, 5 and at the final dose on Day 15), samples will be collected for chemistry, Complete Blood Count (CBC), International normalized ratio (INR), prothrombin time (PT), partial thromboplastin time (PTT), cholesterol, low density lipoprotein (LDL), and high density lipoprotein (HDL), and vitamin K level. Blood samples for PK/PD will be collected 30 minutes prior to the morning dose on Day 5 and Day 15 and also at 0.5, 1, 2, and 4 hours after dosing. Lab samples (chemistry, etc.), will also be drawn at the time of the first PK/PD draw on Day 5 and Day 15.

A phone interview will be conducted no fewer than 25 days and no more than 35 days after the last dose on Day 15 to collect information on concomitant medications and adverse events Graded using Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • Eatontown, New Jersey, United States, 07724
        • Clinilabs Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women, age >18 years
  • Body mass index (BMI)≥19 and ≤30
  • Good health conditions or without significant illness, by judgment of a legally qualified professional, according to the following evaluations: medical history, physical examination, vital signs, electrocardiogram (ECG), and screening or baseline hematology and clinical chemistry measures.

  • Subjects of child bearing potential must agree to use one of the accepted methods of contraception (listed below) during the trial (including the screening period prior to receiving trial medication), at least until return of menstruation after stopping the trial medication.

    • condom (male or female) with spermicide
    • diaphragm or cervical cap with spermicide
    • Intrauterine device (IUD)
    • hormonal contraception and condom (male or female)
  • Female subjects must have a negative pregnancy test result at screening and Day-1
  • PT/PTT/INR within normal limits
  • Vitamin K levels within normal limits
  • Capable of understanding and complying with the protocol and signing informed consent

Exclusion Criteria:

  • Pregnant or lactating female subjects
  • Known hypersensitivity to the study drug (Coenzyme Q10) or to compounds chemically related
  • History or presence of hepatic or gastrointestinal illnesses, or other condition that interferes with the drug's absorption, distribution, excretion or metabolism
  • History of hepatic, renal, pulmonary, gastrointestinal, epileptic, hematologic or psychiatric illness
  • Hypotension or hypertension of any etiologic that needs pharmacologic treatment
  • History of or existing coagulopathy
  • History of myocardial infarction, angina, and/or heart insufficiency
  • Non-recommended electrocardiographic findings, according to investigator criteria
  • Results of the laboratory exams out of normal range unless that they are considered as clinically irrelevant by the investigator
  • Subject is a smoker
  • Subject ingests more than 5 cups of coffee or tea a day
  • History of alcohol or drug abuse
  • History of serious adverse reactions or hypersensitivity to any drug
  • On-going regular use of oral prescription drugs, with the exception of oral contraceptives
  • Hospitalization for any reason within 8 weeks prior to study dosing
  • Participation in any experimental study or ingested any experimental drug within 30 days preceding study
  • Donation or loss of 450 mL or more of blood within the 3 months prior to Screening/Baseline
  • Subject consumed alcohol 48 hours prior to the baseline measurements of the study
  • Subject reports history of human immunodeficiency virus
  • Currently using coenzyme Q10 over-the-counter products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BPM31510 Oral Nanosuspension 4%
Study subjects will self-administer 80 mL (4 vials of 20 mL) of oral BPM31510 (Ubidecarenone, USP; 40 mg/mL) nano-suspension 3 times daily every 4 to 6 hours for a total daily dose 9600 mg/day of BPM31510 for 14 consecutive days. The last study dose (morning dose only) is administered at the clinic on Day 15.
Drug: BPM31510 Oral Nanosuspension 4%
Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)
Other Names:
  • Coenzyme Q10, CoQ10, ubidecarenone

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Maximum plasma concentration (Cmax)
Time Frame: Days 1, 2, 5, 15; baseline pre-dosing concentrations
Pharmacokinetic (PK) samples collected to establish oral bioavailability.
Days 1, 2, 5, 15; baseline pre-dosing concentrations
Area under the plasma concentration curve (AUC0-4)
Time Frame: Days 1, 2, 5, 15; baseline pre-dosing concentrations
Pharmacokinetic (PK) samples collected to establish oral bioavailability.
Days 1, 2, 5, 15; baseline pre-dosing concentrations

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of study subjects with adverse events
Time Frame: Baseline to 25-35 days after the end of dosing
A follow-up phone interview with each study subject will occur 25 to 35 days after the end of dosing to measure the number of adverse events that have occurred.
Baseline to 25-35 days after the end of dosing
C-reactive protein measurement
Time Frame: Days 1, 2, 5, 15
Days 1, 2, 5, 15
Cholesterol measurement
Time Frame: Days 1, 2, 5, 15
Days 1, 2, 5, 15
Low density lipoprotein (LDL) measurement
Time Frame: Days 1, 2, 5, 15
Days 1, 2, 5, 15
High density lipoprotein (HDL) measurement
Time Frame: Days 1, 2, 5, 15
Days 1, 2, 5, 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Berg, LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Magdy Shenouda, MD, Clinilabs, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 21, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BP 0312-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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